Label: OXYGEN gas
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Contains inactivated NDC Code(s)
NDC Code(s): 65567-001-01, 65567-001-02, 65567-001-03 - Packager: Central Montana Medical Facilities, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 21, 2017
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PRINCIPAL DISPLAY PANEL
OXYGEN, REFRIGERATED LIQUID USP UN1073 OXYGEN 2
WARNING: For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx Only.
Uninterrupted use of high concentration of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjucation with resuscitative equipment.
STORAGE AND HANDLING:
Always keep container in upright position. WARNING: EXTREMELY COLD, OXIDIZING LIQUID AND GAS UNDER PRESSURE. VIGOROUSLY ACCELERATES COMBUSTION. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. CAN CAUSE SEVERE FROSTBITE.
Keep oil, grease, and combustibles away. Use with equipment cleaned for oxygen service. Store and use with adequate ventilation. Do not get liquid in eyes, on skin, or clothing. For liquid withdrawal, wear face shield and gloves. Do not drop. Use hand truck for container movement. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. FIRST AID IN CASE OF FROSTBITE, obtain medical treatment immediately.
PRODUCED BY AIR LIQUEFACTION.
DO NOT REMOVE THIS PRODUCT LABEL.
CMMC Home Medical Equipment
Lewistown, MT 59715
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INGREDIENTS AND APPEARANCE
OXYGEN
oxygen gasProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65567-001 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 990 mL in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65567-001-01 595 L in 1 DEWAR; Type 0: Not a Combination Product 04/20/2000 2 NDC:65567-001-02 878 L in 1 DEWAR; Type 0: Not a Combination Product 04/20/2000 3 NDC:65567-001-03 1161 L in 1 DEWAR; Type 0: Not a Combination Product 04/20/2000 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA205820 04/20/2000 Labeler - Central Montana Medical Facilities, Inc. (071761563) Establishment Name Address ID/FEI Business Operations Central Montana Medical Facilities, Inc. 021990552 manufacture(65567-001)